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LifeCodexx to Launch Sequencing-based Trisomy 21 Test in Q2

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LifeCodexx, a subsidiary of German sequencing service provider GATC Biotech, plans to launch its non-invasive prenatal trisomy 21 test, called LifeCodexx PraenaTest, in the second quarter of this year, the company said this week.

The firm has obtained more than 500 blood samples for its ongoing prospective blinded clinical study, which is comparing the test with conventional invasive testing methods.

Results of the study, which GATC Biotech and LifeCodexx are conducting in partnership with several European prenatal diagnostics centers, will be available in the first quarter, and LifeCodexx plans to introduce the test in German-speaking countries in the second quarter.

Multiplexing of the test, which runs on the Illumina HiSeq 2000, has been increased from seven to 12 samples, resulting in cost reductions, according to the company. In addition, physicians will no longer need to prepare plasma from the blood samples they take and can ship the samples at ambient temperature.

Last summer, LifeCodexx licensed intellectual property surrounding the test method from Sequenom (CSN 8/17/2011), which markets a similar test, MaterniT21, in the US. Sequenom also recently said that it has improved its sample collection process (CSN 12/21/2011).

Both LifeCodexx and Sequenom are working on additional tests to diagnose trisomy 13 and 18, and LifeCodexx is developing another test for preeclampsia.

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